ISRCTN92382106Completed未知
The effectiveness of an integrated cardioprotective dietary intervention compared with an average UK diet in reducing cardiovascular disease risk factors in older men and women aged 40 - 70 years
King's College London (KCL) (UK)0 sites196 target enrollmentStarted: October 11, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 196
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Healthy men and women, aged 40 - 70 years
Exclusion Criteria
- •1. A reported history of angina, myocardial infarction, peripheral vascular disease, congenital heart disease or stroke
- •2. Asymptomatic atrial fibrillation
- •3. Type 1 or type 2 diabetes mellitus (fasting plasma glucose greater than 7 mmol/L)
- •4. Seated blood pressure greater than 160/105 mmHg
- •5. Current use of medication for lowering blood cholesterol (statins) or blood pressure
- •6. Body mass index less than 18.5 and greater than 35 kg/m2
- •7. An overall risk of cardiovascular disease over the next ten years of greater than 20% assessed according to current NICE guidelines in combination with untreated high blood pressure or raised cholesterol
- •8. Clinical history of cancer (excluding basal cell carcinoma) in the past five years
- •9. Chronic renal, liver or inflammatory bowel disease
- •10. Current cigarette smoker (confirmed by urinary cotinine analysis)
- •11. History of substance abuse or alcoholism (previous weekly alcohol intake greater than 60 units/men or 50 units/women)
- •12. Current self-reported weekly alcohol intake not exceeding 21 units for women and 28 for men
- •13. Currently pregnant, planning pregnancy or having had a baby in the last 12 months
- •14. Unwilling to follow the protocol and/or give informed consent
- •15. Unwilling to refrain from use of dietary supplements
- •16. Unwilling to restrict consumption of oily fish
- •17. Weight change of greater than 3 kg in preceding 2 months
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